Roth Net Polyp Retrieval
FDA device recall Z-1416-2017 · posted 2017-03-08 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
- Action taken
- US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers. The firm requested their customers to do the following: 1. Quarantine and destroy the affected Roth Net devices in your inventory. 2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product. 3. Complete and return the attached Response Card. For further information please call (440) 358-6055.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 2,131 units
- Distribution
- US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ire
- Date initiated
- 2016-12-13
- Date posted
- 2017-03-08
- Date terminated
- 2017-06-13
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROTH NET RETRIEVER (K122462) | United States Endoscopy Group, Inc. | 2012-09-11 |